FDA.reportPublic FDA data

BioPerfect Instant Hand Sanitizer

Manufacturer
Shandong Renrui Biotechnology Co, Ltd.
Effective date
2020-06-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:20:53

Label at a glance#

ProductBioPerfect Instant Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

hand sanitizer to help decrease bacteria on the skin. when water, soap & towel are not available. recommended for repeated use

Dosage and administration

pumps as needed into your palms and thoroughly spread on both hands. rub into skin until dry.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • hand sanitizer to help decrease bacteria on the skin.
  • when water, soap & towel are not available.
  • recommended for repeated use

Warnings

WARNINGS SECTION

  • For external use only 
  • Flamable
  • Keep away from fire or flame.

Do not apply around eyes. Do not use

OTC - DO NOT USE SECTION

in ears and mouth.

When using this product,

OTC - WHEN USING SECTION

avoid contact with eyes. In case of contact flush eyes with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children must be supervised in use of this product.

Directions

DOSAGE & ADMINISTRATION SECTION

  • pumps as needed into your palms and thoroughly spread on both hands.
  • rub into skin until dry.

Other information

SPL UNCLASSIFIED SECTION

  • store at 20 °C (68 °to 77° F)
  • may discolor fabrics

Inacive ingredients

INACTIVE INGREDIENT SECTION

Water, Isopropyl alcohol, Carbomer, Triethanolamine, Glycerin, Tocopheryl Acetate, Aloe Vera Leaf Juice.

Package Labeling:30ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label1Label1

Package Labeling:60ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling:300ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

Package Labeling:500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

Package Labeling:3785ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5Label5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1047755ethanol 75 % Topical SolutionPSN1
1047755ethanol 0.75 ML/ML Topical SolutionSCD1
1047755ethanol 75 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77985-001-012022-01-28C16284748780-1d6a99b39-dad1-a426-e053-dadaa90af4c2BioPerfect Instant Hand Sanitizer
77985-001-022022-01-28C16284748780-1d6a99b39-dad1-a426-e053-dadaa90af4c2BioPerfect Instant Hand Sanitizer
77985-001-032022-01-28C16284748780-1d6a99b39-dad1-a426-e053-dadaa90af4c2BioPerfect Instant Hand Sanitizer
77985-001-042022-01-28C16284748780-1d6a99b39-dad1-a426-e053-dadaa90af4c2BioPerfect Instant Hand Sanitizer
77985-001-052022-01-28C16284748780-1d6a99b39-dad1-a426-e053-dadaa90af4c2BioPerfect Instant Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77985-001-01BioPerfect Instant Hand Sanitizer30 mL in 1 BOTTLELIQUID301
77985-001-02BioPerfect Instant Hand Sanitizer60 mL in 1 BOTTLELIQUID601
77985-001-03BioPerfect Instant Hand Sanitizer300 mL in 1 BOTTLELIQUID3001
77985-001-04BioPerfect Instant Hand Sanitizer500 mL in 1 BOTTLELIQUID5001
77985-001-05BioPerfect Instant Hand Sanitizer3785 mL in 1 BOTTLELIQUID37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77985-001BIOPERFECT INSTANT HAND SANITIZER (ALCOHOL) LIQUID [SHANDONG RENRUI BIOTECHNOLOGY CO, LTD.]1Legacy NDC, 5 package rows20200710_c358677c-5db6-4a91-b093-6e6ea94e13fa.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77985-00177985-001-01, 77985-001-02, 77985-001-03, 77985-001-04, 77985-001-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a793537b-fbea-3f88-e053-2995a90a0151c358677c-5db6-4a91-b093-6e6ea94e13fa2020-06-08WarningsExact identifier
spl id: a793537b-fbea-3f88-e053-2995a90a0151
spl set id: c358677c-5db6-4a91-b093-6e6ea94e13fa

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.